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Document Control
Document Control Regulatory Affairs is an exciting career that requires a dynamic individual capable of handling a multitude of job tasks. Finding a position in Document Control is easy at We offer excellent job opportunities across the United States and have simplified the hiring process. By clicking on the job title that matches your qualifications you can apply directly to the hiring company. Whether you are embarking on a new career or looking for an advanced position has the right Document Control career for you!
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Sr. Quality Engineer, Lab Equipment

Novartis Pharmaceuticals - Huntington, WV

Bachelor's degree in a Science or Engineering related field, or 10 years of relevant experience. Preferred Master's degree in a Science or Engineering related field. Any Bachelor's degree with one certification (ASQ CQA, or ASQ CQE, o Excellent knowledge of English and local site language 3-5 years experience with at least 1-3 years in a medical device/ pharmaceutical manufacturing environment or ...more

From Novartis Pharmaceuticals - 4/17/2018 8:00:12 AM

Principal Medical Communications Scientist

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Main Duties and Responsibilities As a Principal MCS, you will •provide expert communications leadership to late-stage drug projects (Phase 3 onwards) in a world-leading biopharmaceutical company •lead a strategy-driven approach to authoring clinical documents for submissions.  You will liaise with senior project staff, prospectively develop a storyboard for the submission, and plan docume...more

From AstraZeneca Pharmaceuticals - 4/17/2018 5:43:58 AM

Quality Assurance Manager

Catalent Pharma Solutions - Woodstock, IL

The Role •Define and manage the training, education, and development of the employees at the site, both directly and through staff members •Complete comprehensive review and assessment of Quality documents associated with the production and packaging of Blow/Fill/Seal (BFS) products for adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) •Coordinat...more

From Catalent Pharma Solutions - 4/9/2018 5:52:27 AM

Sr. Manager/Associate Director, Regulatory Affairs

Sun Pharma - Hawthorne, NY

• BA/BS and science where pharmacy related field. Position to be commiserated with education and pharmaceutical industry experience • Regulatory affairs certification is desirable • Minimum 5 to 7 years regulatory experience in submissions to FDA in the generic pharmaceutical industry • Strong background in eCTD and preferably in labeling as well. • Experience in OTC monograph is p...more

From Sun Pharma - 3/23/2018 2:28:04 AM

Quality Services Cooordinator

Catalent Pharma Solutions - Kansas City, MO

The Role (daily responsibilities) GMP Functions: •Issues and maintains site organizational charts monthly and quarterly. •Manages documents for the monthly Management Review for the attendance, presentation and meeting notes for the official copy and distribution to personnel. •Fill requests for number issuance for Investigations, Risk Assessments, Analytical Result Forms and LIMS Data Event ...more

From Catalent Pharma Solutions - 3/19/2018 5:42:38 AM

Director Quality

Catalent Pharma Solutions - Eberbach, Baden-Württemberg

The Role •Develop and implement Site Quality Plan, Quality Unit objectives and related procedures. •Maintain and enhance an effective Quality Management System (QMS) •Interface with all other departments to ensure compliance with cGLP/cGMP. •Monitor site compliance to FDA, EU and all other applicable requirements. •Establish a process to review and Implements site procedures in align...more

From Catalent Pharma Solutions - 3/15/2018 5:54:04 AM

Quality Operations Director

Catalent Pharma Solutions - Brussels, Région de Bruxelles-Capitale

The Role •Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. •Develop and implement Site Quality Plan, Quality Unit objectives and related procedures. •Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations. •Interface with all other departments to ensure compliance with cGMP....more

From Catalent Pharma Solutions - 2/28/2018 5:46:06 AM

Engineering Documentation Specialist

AstraZeneca Pharmaceuticals - Coppell, TX

Key Accountabilities: •         Ethical conduct and compliance •         Escalates quality issues or potential non-compliance to F/E Management •         Write, edit, and review Standard Operating Procedures and various technical documents (protocols, specification, work instructions, etc.) in a collaborative environment with Facilities & Engineering staff. •         Conduct investigations ...more

From AstraZeneca Pharmaceuticals - 2/21/2018 5:41:13 AM

Sr. Compliance Auditor

Catalent Pharma Solutions - Woodstock, IL

Job Description •Manages, leads, and conducts audits (customer, external, and internal).  Includes risk assessments, scheduling, preparing documents prior to the audit, creating PRs in TrackWise and managing audit during execution, and closure •Lead preparations for planned Health Authority Inspections.  •Lead of site Supplier Review Board •Support and implement Central Supplier Quality ...more

From Catalent Pharma Solutions - 2/12/2018 5:48:06 AM
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